Pemphigus VulgarisPhase 2NCT04023149
Efficacy of Interleukin-2 Gargle in the Treatment of Oral Mucosa Lesion in Pemphigus Vulgaris
A Phase 2 study testing recombinant human interleukin-2 (rhIL-2) in people with Pemphigus Vulgaris, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This clinical study will test the short-term efficacy of interleukin-2 gargle combined with systemic use of glucocorticoids in the treatment of oral mucosal lesions in mucosal-dominant pemphigus vulgaris and moderate mucocutaneous pemphigus vulgaris. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pemphigus Vulgaris
- What is being tested?
- recombinant human interleukin-2 (rhIL-2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2020to 1 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: between 18 years and 70 years;
- Patients definitely diagnosed with pemphigus vulgaris according to 'Diagnostic Criteria for Pemphigus Vulgaris (Autoimmune Disease Sub-Professional Committee of Dermatologist Branch of Chinese Medical Doctor Association)'; or pemphigus vulgaris has been diagnosed in the past.
- Visible oral mucosa lesion due to pemphigus;
- Mucosal-dominant PV or moderate mucocutaneous PV (PDAI score: 15-45);
- Written informed consent was obtained, volunteer to participate in the project and complete as required.
Who cannot join
- Patients with severe diseases of heart, brain, lungs, liver, kidney or blood system; patients experienced organ transplantation;
- Patients with any acute severe infection such as pyemia and cellulitis, active tuberculosis, or an infection history of human immunodeficiency virus (HIV);
- Patients with allergic skin diseases with obvious pruritus such as eczema or urticaria, blood routine examination show elevated eosinophils or have a clear history of allergy to rhIL-2;
- Patients with persistent ventricular tachycardia, uncontrolled arrhythmias, chest pain with ECG changes, angina or myocardial infarction, cardiac tamponade;
- Patients with nausea, vomiting, peptic ulcer or intestinal ischemia;
- Patients with drug abuse, alcohol abuse, or mental disorders that are unable to cooperate or adhere to treatment;
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- Pregnant women, lactating women or women who are ready to conceive within 3 months;
- Patients receiving treatment of immunosuppressants in the last 3 months;
- Patients receiving continuous treatment of glucocorticoids with a dose of more than 0.75 mg/kg/d in the last 2 weeks;
- Patients with oral fungal infection but don't receive antifungal therapy;
- Participated in other clinical trials within 3 months before the screening.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Xiangqi Tang, MD, PhD, +86-731-84896038, xiangyagcp@126.com
Qianjin Lu, MD, PhD
About this study
Official title: Short-term Efficacy of Interleukin-2 Gargle Combined With Systemic Use of Glucocorticoids in the Treatment of Oral Mucosal Lesion in Pemphigus Vulgaris: a Randomized, Controlled, Double-blind, Multicenter Clinical Study
This clinical study will test the short-term efficacy of interleukin-2 gargle combined with systemic use of glucocorticoids in the treatment of oral mucosal lesions in mucosal-dominant pemphigus vulgaris and moderate mucocutaneous pemphigus vulgaris.
Read the detailed description
Backgrounds: Pemphigus vulgaris (PV) is a life-threatening autoimmune bullous skin disease characterized by blisters or bullae on the skin and mucosal membranes. The formation of painful erosion surface after rupture of blisters may result in infection, haemorrhage and even electrolyte imbalance due to excessive water loss. PV can be divided into two types: mucocutaneous PV and mucosal-dominant PV. Patients with mucocutaneous PV not only suffer from severe mucosal damage but also general skin lesions, while slight or no skin lesions involved in patients with mucosal-dominant PV. Oral mucosal damage occurred 3 months to 1 year before skin lesions in about 60% of PV patients. The most common involving parts of the oral mucosa are pars buccalis and oropharynx, presenting with persistent and painful erosion or ulceration, which leads to difficulty in feeding and aggravates the electrolyte imbalance.
Glucocorticoid is the main treatment strategy of PV. Besides the blisters and erosion, complications of long-term use of glucocorticoid are also the death causes of PV patients, such as osteoporosis, hyperglycemia, hypertension, hypokalemia, femoral head necrosis, peptic ulcer, and infection. Many patients have gotten remission from the standard application of glucocorticoids, Immunosuppressants and biological agent. However, there is still a part of patients that are insensitive to these drugs or intolerant the side effects of corticosteroids. Even for those steroid-sensitive patients, the healing of oral mucosa often takes a long course, lasting from weeks to months, which has a serious impact on the quality of life. It is a critical problem to develop novel therapeutics to accelerate the healing of oral mucosa.
Recombinant human interleukin-2 (rhIL-2) is an immunomodulator agent commonly used in the treatment of patients with tumours. The safety and efficacy of low dose rhIL-2 have been demonstrated in the treatment of type I diabetes, systemic lupus erythematosus, and graft-versus-host disease. We found that topical application of rhIL-2 can effectively relieve pain and improve the condition of oral mucosa for PV patients. Studies have shown that IL-2 selectively modulates CD4+ T cell subsets and increases the amounts and function of regulatory T cells. Moreover, IL-2 plays an important role in the proliferation of fibroblasts and wound healing. These evidences provide us the theoretical basis to explore the potential mechanism of rhIL-2 in treatment of mucosal damage of patients with PV.
Design of Study: This is a randomized, controlled, double-blind, multicenter clinical trial to assess the safety and short-term efficacy of rhIL-2 for oral erosion in patients with pemphigus.
Methods: rhIL-2 oral gargle combined with the standard dose of glucocorticoids (mucosal-dominant PV: prednisone 0.5 mg/kg/d, mucocutaneous PV: prednisone 1 mg/kg/d) will be applied to pemphigus patients meeting the inclusion criteria. The end points include clinical response and immunological changes, as well as safety.
- Conditions
- Pemphigus Vulgaris
- Being tested
- recombinant human interleukin-2 (rhIL-2), placebo
- Keywords
- pemphigus vulgaris, oral mucosal lesion, interleukin-2
- Medical subject headings
- Pemphigus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human interleukin-2 (rhIL-2)Drug
Drug: rhIL-2; Pharmaceutical form: solution; Route of administration: oral gargle.
placeboDrug
Drug: placebo; Pharmaceutical form: solution; Route of administration: oral gargle.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patients will receive rhIL-2 solution oral gargle twice per day (2 million units of rhIL-2 dissolved in 5ml normal saline for each dose, garble for 3 minutes) and continue for 3 weeks. A standard dose of glucocorticoids (mucosal-dominant PV: prednisone 0.5 mg/kg/d, moderate mucocutaneous PV: prednisone 0.75 mg/kg/d) will be applied at the same time. Receives: Drug: recombinant human interleukin-2 (rhIL-2) |
| control group | Placebo comparator | Patients will receive placebo solution oral gargle twice per day (5ml for each dose, garble for 3 minutes) and continue for 3 weeks. A standard dose of glucocorticoids (mucosal-dominant PV: prednisone 0.5 mg/kg/d, moderate mucocutaneous PV: prednisone 0.75 mg/kg/d) will be applied at the same time. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The decline of the oral mucosa score of Pemphigus Disease Area Index (PDAI) after a 21-day treatment.
(PDAI score on Day 0 - PDAI score on Day 21)/PDAI score on Day 0 × 100%
Measured: from baseline to 21 days treatment
Secondary outcomes (13)
The decline of the oral mucosa score of Pemphigus Disease Area Index (PDAI) after a 7-, 14-, 28- and 42-day treatment, respectively.
(PDAI score on Day 0 - PDAI score on Day N)/PDAI score on Day 0 × 100%
Measured: from baseline to 7, 14, 28 and 42 days, respectively
The decline of Oral Disease Severity Score (ODSS) after a 7-, 14-, 21-, 28- and 42-day treatment, respectively.
(ODSS on Day 0 - ODSS on Day N)/ODSS on Day 0 × 100%
Measured: from baseline to 7, 14, 21, 28 and 42 days, respectively
The decline of oral mucosa Visual Analogue Scale(VAS) after a 7-, 14-, 21-, 28- and 42-day treatment, respectively.
(VAS on Day 0 - VAS on Day N)/VAS on Day 0 × 100%
Measured: from baseline to 7, 14, 21, 28 and 42 days, respectively
The decline of Physician's Global Assessment (PGA) score for oral mucosa damage after a 7-, 14-, 21-, 28- and 42-day treatment, respectively.
(PGA score on Day 0 - PGA score on Day N)/PGA score on Day 0 × 100%
Measured: from baseline to 7, 14, 21, 28 and 42 days, respectively
The decline of sera autoantibodies titer after a 21- and 42-day treatment, respectively.
The autoantibodies including anti-Dsg3 and anti-Dsg1 antibodies titer are detected by ELISA
Measured: from baseline to 21 and 42 days, respectively
The dose of glucocorticoids on Day 28 and Day 42, respectively.
prednisone (mg/d)
Measured: 28 and 42 days
The percentage of patients receiving incremental dose of glucocorticoids, steroid pulse therapy, or combined with immunosuppressants/intravenous immunoglobulin(IVIG)/biological agents on Day 28 and Day 42, respectively.
Measured: 28 and 42 days
The percentage of patients from whose oral mucosa the fungal infection can be detected on Day 21 and Day 42.
Measured: 21 and 42 days
The change of white blood cell (WBC) counts on Day 21 and Day 42.
The unit of WBC: 10^9/L
Measured: 21 and 42 days
The change of serum potassium level on Day 21 and Day 42.
The unit of serum potassium level: mmol/L
Measured: 21 and 42 days
The change of fasting blood-glucose (FBS) level on Day 21 and Day 42.
The unit of FBS level: mmol/L
Measured: 21 and 42 days
The change of serum albumin level on Day 21 and Day 42.
The unit of serum albumin level: g/L
Measured: 21 and 42 days
The safety evaluation about the drug adverse reactions throughout the entire study process.
the adverse reactions of rhIL-2 include fever, shiver, muscular soreness, nausea, emesis, rash, capillary leak syndrome.
Measured: through study completion, an average of 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start2 Apr 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pemphigus VulgarisStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qianjin Lu, MD, PhD, Second Xiangya Hospital of Central South University
- Investigators
- Qianjin Lu, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023149
- Sponsor's protocol ID
- IPOEMS201903
- Status last verified
- Jan 2021
- First submitted
- 3 Jul 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Efficacy of Interleukin-2 Gargle Combined With Systemic Use of Glucocorticoids in the Treatment of Oral Mucosal Lesion in Pemphigus Vulgaris: a Randomized, Controlled, Double-blind, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT04023149
- Acronym / sponsor ID
- IPOEMS201903
- Conditions
- Pemphigus Vulgaris
- Keywords
- pemphigus vulgaris, oral mucosal lesion, interleukin-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study will test the short-term efficacy of interleukin-2 gargle combined with systemic use of glucocorticoids in the treatment of oral mucosal lesions in mucosal-dominant pemphigus vulgaris and moderate mucocutaneous pemphigus vulgaris.
Detailed description
Backgrounds: Pemphigus vulgaris (PV) is a life-threatening autoimmune bullous skin disease characterized by blisters or bullae on the skin and mucosal membranes. The formation of painful erosion surface after rupture of blisters may result in infection, haemorrhage and even electrolyte imbalance due to excessive water loss. PV can be divided into two types: mucocutaneous PV and mucosal-dominant PV. Patients with mucocutaneous PV not only suffer from severe mucosal damage but also general skin lesions, while slight or no skin lesions involved in patients with mucosal-dominant PV. Oral mucosal damage occurred 3 months to 1 year before skin lesions in about 60% of PV patients. The most common involving parts of the oral mucosa are pars buccalis and oropharynx, presenting with persistent and painful erosion or ulceration, which leads to difficulty in feeding and aggravates the electrolyte imbalance.
Glucocorticoid is the main treatment strategy of PV. Besides the blisters and erosion, complications of long-term use of glucocorticoid are also the death causes of PV patients, such as osteoporosis, hyperglycemia, hypertension, hypokalemia, femoral head necrosis, peptic ulcer, and infection. Many patients have gotten remission from the standard application of glucocorticoids, Immunosuppressants and biological agent. However, there is still a part of patients that are insensitive to these drugs or intolerant the side effects of corticosteroids. Even for those steroid-sensitive patients, the healing of oral mucosa often takes a long course, lasting from weeks to months, which has a serious impact on the quality of life. It is a critical problem to develop novel therapeutics to accelerate the healing of oral mucosa.
Recombinant human interleukin-2 (rhIL-2) is an immunomodulator agent commonly used in the treatment of patients with tumours. The safety and efficacy of low dose rhIL-2 have been demonstrated in the treatment of type I diabetes, systemic lupus erythematosus, and graft-versus-host disease. We found that topical application of rhIL-2 can effectively relieve pain and improve the condition of oral mucosa for PV patients. Studies have shown that IL-2 selectively modulates CD4+ T cell subsets and increases the amounts and function of regulatory T cells. Moreover, IL-2 plays an important role in the proliferation of fibroblasts and wound healing. These evidences provide us the theoretical basis to explore the potential mechanism of rhIL-2 in treatment of mucosal damage of patients with PV.
Design of Study: This is a randomized, controlled, double-blind, multicenter clinical trial to assess the safety and short-term efficacy of rhIL-2 for oral erosion in patients with pemphigus.
Methods: rhIL-2 oral gargle combined with the standard dose of glucocorticoids (mucosal-dominant PV: prednisone 0.5 mg/kg/d, mucocutaneous PV: prednisone 1 mg/kg/d) will be applied to pemphigus patients meeting the inclusion criteria. The end points include clinical response and immunological changes, as well as safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: recombinant human interleukin-2 (rhIL-2)Patients will receive rhIL-2 solution oral gargle twice per day (2 million units of rhIL-2 dissolved in 5ml normal saline for each dose, garble for 3 minutes) and continue for 3 weeks. A standard dose of glucocorticoids (mucosal-dominant PV: prednisone 0.5 mg/kg/d, moderate mucocutaneous PV: prednisone 0.75 mg/kg/d) will be applied at the same time. |
| control group | Placebo comparator | Drug: placeboPatients will receive placebo solution oral gargle twice per day (5ml for each dose, garble for 3 minutes) and continue for 3 weeks. A standard dose of glucocorticoids (mucosal-dominant PV: prednisone 0.5 mg/kg/d, moderate mucocutaneous PV: prednisone 0.75 mg/kg/d) will be applied at the same time. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: between 18 years and 70 years;
- Patients definitely diagnosed with pemphigus vulgaris according to 'Diagnostic Criteria for Pemphigus Vulgaris (Autoimmune Disease Sub-Professional Committee of Dermatologist Branch of Chinese Medical Doctor Association)'; or pemphigus vulgaris has been diagnosed in the past.
- Visible oral mucosa lesion due to pemphigus;
- Mucosal-dominant PV or moderate mucocutaneous PV (PDAI score: 15-45);
- Written informed consent was obtained, volunteer to participate in the project and complete as required.
Key exclusion criteria (11 listed)
- Patients with severe diseases of heart, brain, lungs, liver, kidney or blood system; patients experienced organ transplantation;
- Patients with any acute severe infection such as pyemia and cellulitis, active tuberculosis, or an infection history of human immunodeficiency virus (HIV);
- Patients with allergic skin diseases with obvious pruritus such as eczema or urticaria, blood routine examination show elevated eosinophils or have a clear history of allergy to rhIL-2;
- Patients with persistent ventricular tachycardia, uncontrolled arrhythmias, chest pain with ECG changes, angina or myocardial infarction, cardiac tamponade;
- Patients with nausea, vomiting, peptic ulcer or intestinal ischemia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant human interleukin-2 (rhIL-2)Drug: rhIL-2; Pharmaceutical form: solution; Route of administration: oral gargle. | Drug | experimental group |
| placeboDrug: placebo; Pharmaceutical form: solution; Route of administration: oral gargle. | Drug | control group |
Primary outcome
The decline of the oral mucosa score of Pemphigus Disease Area Index (PDAI) after a 21-day treatment.
Time frame: from baseline to 21 days treatment
(PDAI score on Day 0 - PDAI score on Day 21)/PDAI score on Day 0 × 100%
13 secondary outcomes
The decline of the oral mucosa score of Pemphigus Disease Area Index (PDAI) after a 7-, 14-, 28- and 42-day treatment, respectively.
Time frame: from baseline to 7, 14, 28 and 42 days, respectively
The decline of Oral Disease Severity Score (ODSS) after a 7-, 14-, 21-, 28- and 42-day treatment, respectively.
Time frame: from baseline to 7, 14, 21, 28 and 42 days, respectively
The decline of oral mucosa Visual Analogue Scale(VAS) after a 7-, 14-, 21-, 28- and 42-day treatment, respectively.
Time frame: from baseline to 7, 14, 21, 28 and 42 days, respectively
The decline of Physician's Global Assessment (PGA) score for oral mucosa damage after a 7-, 14-, 21-, 28- and 42-day treatment, respectively.
Time frame: from baseline to 7, 14, 21, 28 and 42 days, respectively
The decline of sera autoantibodies titer after a 21- and 42-day treatment, respectively.
Time frame: from baseline to 21 and 42 days, respectively
The dose of glucocorticoids on Day 28 and Day 42, respectively.
Time frame: 28 and 42 days
The percentage of patients receiving incremental dose of glucocorticoids, steroid pulse therapy, or combined with immunosuppressants/intravenous immunoglobulin(IVIG)/biological agents on Day 28 and Day 42, respectively.
Time frame: 28 and 42 days
The percentage of patients from whose oral mucosa the fungal infection can be detected on Day 21 and Day 42.
Time frame: 21 and 42 days
The change of white blood cell (WBC) counts on Day 21 and Day 42.
Time frame: 21 and 42 days
The change of serum potassium level on Day 21 and Day 42.
Time frame: 21 and 42 days
The change of fasting blood-glucose (FBS) level on Day 21 and Day 42.
Time frame: 21 and 42 days
The change of serum albumin level on Day 21 and Day 42.
Time frame: 21 and 42 days
The safety evaluation about the drug adverse reactions throughout the entire study process.
Time frame: through study completion, an average of 42 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qianjin Lu principal investigator
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant human interleukin-2 (rhIL-2) in people with Pemphigus Vulgaris, run by Second Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qianjin Lu, MD, PhD (+86-13787097676, qianlu5860@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The decline of the oral mucosa score of Pemphigus Disease Area Index (PDAI) after a 21-day treatment. (time frame: from baseline to 21 days treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.